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Cellular Adoptive Immunotherapy and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: October 6, 2004   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093574
  Purpose

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Combining biological therapy with interleukin-2 may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cellular adoptive immunotherapy together with interleukin-2 works in treating patients with metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Biological: filgrastim
Biological: therapeutic autologous lymphocytes
Biological: therapeutic tumor infiltrating lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Interleukin-2 Aldesleukin Filgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study in Metastatic Renal Cell Cancer Using Cultured, Tumor-Reactive Lymphocytes and Interleukin-2

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical tumor regression [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2004
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine whether adoptive T-lymphocyte transfer combined with interleukin-2 results in clinical tumor regression in patients with metastatic renal cell cancer.

OUTLINE: Tumor-reactive T-lymphocytes are isolated from tumor-infiltrating lymphocytes, peripheral blood mononuclear cells, or lymph nodes and expanded in vitro. Several months later, eligible patients receive cultured T-lymphocytes IV over 10-20 minutes followed by interleukin-2 (IL-2) IV over 15 minutes every 8 hours for up to 12 doses. Approximately 1 month later, patients are evaluated. Responding patients continue to receive T-lymphocytes and IL-2 until the cells are used up in the absence of disease progression or unacceptable toxicity. Non-responding patients receive a preparative regimen comprised of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. Beginning on day 0, patients receive the cultured T-lymphocytes and IL-2 as before. They also receive filgrastim (GM-CSF) subcutaneously daily until blood counts recover.

Treatment may be repeated once approximately 1 month later in the absence of unacceptable toxicity or disease progression AND provided there are an adequate number of cells.

PROJECTED ACCRUAL: A total of 29-100 patients (a maximum of 29 to be treated) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of renal cell carcinoma (RCC)

    • Metastatic disease
  • Measurable disease
  • Tumor progression after treatment with interleukin-2 (only patients receiving cell infusions)
  • Asymptomatic brain metastases allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • Platelet count > 100,000/mm^3
  • No coagulation disorders

Hepatic

  • ALT and AST < 3 times upper limit of normal
  • Total bilirubin ≤ 1.6 mg/dL OR
  • Direct bilirubin ≤ 0.5 mg/dL
  • Hepatitis B negative

Renal

  • Creatinine ≤ 1.6 mg/dL

Cardiovascular

  • No major cardiovascular illness
  • Normal stress cardiac test* NOTE: *For patients with EKG abnormalities, symptoms of cardiac ischemia or arrhythmias, or age > 50 years

Pulmonary

  • No major respiratory illness
  • FEV_1 > 60 % of predicted* NOTE: *For patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction

Immunologic

  • No active systemic infections
  • No major immune system illness
  • HIV negative
  • Epstein-Barr virus positive

Other

  • No contraindication to interleukin-2 therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent steroid therapy

Radiotherapy

  • Prior local radiotherapy to non-evaluated sites allowed

Surgery

  • Not specified

Other

  • More than 4 weeks since prior potentially effective therapy for RCC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093574

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: James C. Yang, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000389227, NCI-04-C-0277, NCI-5774
Study First Received: October 6, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00093574     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Antimetabolites
Urinary Tract Neoplasm
Immunologic Factors
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Renal Cancer
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Kidney Diseases
Analgesics
Alkylating Agents
Kidney Cancer
Anti-HIV Agents
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Recurrence
Carcinoma
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Carcinoma, Renal Cell
Peripheral Nervous System Agents
Fludarabine
Antineoplastic Agents, Alkylating
Adenocarcinoma
Antirheumatic Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Urologic Diseases
Sensory System Agents
Kidney Neoplasms
Therapeutic Uses
Analgesics
Kidney Diseases
Alkylating Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Aldesleukin
Analgesics, Non-Narcotic
Interleukin-2

ClinicalTrials.gov processed this record on May 07, 2009